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The BLUEDIAMOND IMPLANT is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delaved loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm, It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. It is specifically recommended for: - Fixed partial dentures/splinted units (one implant per unit) - Pontic cases in combination with at least one longer implant - Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function. It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part. The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length. The BLUEDIAMOND IMPLANT is consisted of the following components. BLUEDIAMOND IMPLANT Cuff Type: The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function. Material: CP Ti Grade 4 of ASTM F67 Dimension (mm): - Normal Thread Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0); Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0) - Deep Thread Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0) Diameter X Total Length (Thread Length): - Normal Thread Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0) - Deep Thread Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0) Implanted Length (Thread to Shoulder Height): 2.0, 3.0, 4.0 Gingival (Cuff) Height: Not Found The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.

R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only. R2GATE Lite ™ allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).

The proposed device, R2GATE Lite ™ software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096). The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review. R2GATE Lite TM let the user view, measure, zoom and rotate 2D and 3D images of dental implant plans generated by R2GATE Window (K190096). R2GATE Lite TM can be used by dental professionals as a patient consultation tool for planning dental implant surgery and treatment. R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.

The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.

The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.

The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

The ST Internal Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The abutment is a superstructure of a dental implant system which is attached to the implants made of Ti-6A1-4V ELI with the surface treated by anodizing method(except healing and temporary abutment). The ST Internal Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. The system is consisted of the following components: ST Internal Fixture, EZ Post Abutment, Solid Abutment, Angled Abutment, Milling Abutment, Cover Screw, Healing Abutment, Temporary Abutment, and Abutment Screw.